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High-stability simvastatin tablet and preparation method thereof

A high-stability, simvastatin technology, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of high requirements for excipients and equipment, high requirements for production equipment, and poor stability and other problems, to achieve the effect of suitable disintegration time, good fluidity and high stability

Active Publication Date: 2015-12-02
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN103356494A adopts simvastatin coating and then dry pressing method with other auxiliary materials twice to improve the stability of simvastatin tablets, which solves the problem that the stability of simvastatin tablets in the prior art is poor, but this method is harmful to production High equipment requirements and troublesome production
[0005] CN103330692A provides a simvastatin component with improved stability and a preparation method thereof. The formulation, dosage and addition method of auxiliary materials are reasonably selected in a manner without adding an antioxidant to maintain the stability of simvastatin, but the method is direct compression , higher requirements on auxiliary materials and equipment

Method used

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  • High-stability simvastatin tablet and preparation method thereof
  • High-stability simvastatin tablet and preparation method thereof
  • High-stability simvastatin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Simvastatin tablets include the following components: 10g of simvastatin, 15g of pregelatinized starch, 0.05g of butylated hydroxyanisole, 0.5g of povidone K, 50g of lactose, 40g of microcrystalline cellulose, 4g of hydroxypropyl cellulose, Hypromellose 1g, magnesium stearate 0.6g, micro silica gel 1.2g.

[0049] Above-mentioned simvastatin tablet is prepared by following method:

[0050] Weigh each component according to the formula, pass each component through an 80-mesh sieve, and set aside; bake the pregelatinized starch at 105°C for 2 hours, and set aside; dissolve povidone K30 in absolute ethanol to prepare mass Concentration is 12% dehydrated ethanol solution, standby; Hypromellose is dissolved in water B to make the aqueous solution with mass concentration of 2%, standby;

[0051] Mix simvastatin and pregelatinized starch evenly, dissolve butylated hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute ethanol solution to make the abo...

Embodiment 2

[0056] Simvastatin tablets include the following components: 10g of simvastatin, 10g of pregelatinized starch, 0.04g of butylated hydroxyanisole, 300.3g of povidone K, 48g of lactose, 38g of microcrystalline cellulose, and 3.5g of hydroxypropyl cellulose , hypromellose 0.8g, magnesium stearate 0.4g, micro silica gel 0.8g.

[0057] Above-mentioned simvastatin tablet is prepared by following method:

[0058] Weigh each component according to the formula, pass each component through a 60-mesh sieve, and set aside; bake the pregelatinized starch at 100°C for 2 hours, and set aside; dissolve povidone K30 in absolute ethanol to make a mass 10% dehydrated ethanol solution for subsequent use; dissolving hypromellose in water ethyl alcohol to prepare an aqueous solution with a mass concentration of 1% for subsequent use;

[0059] Mix simvastatin and pregelatinized starch evenly, dissolve butyl hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute ethanol so...

Embodiment 3

[0064] Simvastatin tablets include the following components: 20g of simvastatin, 15g of pregelatinized starch, 0.05g of butylated hydroxyanisole, 0.8g of povidone K, 52g of lactose, 42g of microcrystalline cellulose, and 4.5g of hydroxypropyl cellulose , hypromellose 1.5g, magnesium stearate 1.0g, micro silica gel 1.8g.

[0065] Above-mentioned simvastatin tablet is prepared by following method:

[0066] Weigh each component according to the formula, pass each component through a 100-mesh sieve, and set aside; bake the pregelatinized starch at 110°C for 3 hours, and set aside; dissolve povidone K30 in absolute ethanol to prepare mass Concentration is 15% absolute ethanol solution, for subsequent use; Hypromellose is dissolved in water B to make an aqueous solution with a mass concentration of 3%, for subsequent use;

[0067] Mix simvastatin and pregelatinized starch evenly, dissolve butylated hydroxyanisole in absolute ethanol; use the above-mentioned povidone K30 absolute et...

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Abstract

The invention discloses a high-stability simvastatin tablet. The high-stability simvastatin tablet is prepared from, by weight, 5-20 parts of simvastatin, 8-20 parts of pre-gelatinized starch, 0.03-0.06 part of butyl hydroxy anisd, 0.3-1 part of povidone K30, 45-55 parts of lactose, 35-45 parts of microcrystalline cellulose, 3-5 parts of hydroxypropyl cellulose, 0.5-2 parts of hydroxypropyl methylcellulose, 0.2-1.2 parts of magnesium stearate and 0.6-2.4 parts of differential silica gel. Two-part pelleting is adopted in preparation of the simvastatin tablet, simvastatin and pre-gelatinized starch are baked through absolute ethyl alcohol at low temperature, and degradation of simvastatin is avoided; the other part is baked at high temperature. The prepared particles are good in compressibility and fluidity. The prepared tablet is proper in disintegration time, the content, content uniformity and dissolution rate of the tablet all meet requirements, high stability is achieved, a production method is simple, and the high-stability simvastatin tablet is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a highly stable simvastatin tablet and a preparation method thereof. Background technique [0002] Simvastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, and is a highly effective hypolipidemic drug. Simvastatin can block the synthesis of cholesterol. Its functions are as follows: 1. Competitively inhibit the rate-limiting enzyme in the cholesterol synthase system - methylhydroxyglutaryl-CoA reductase, so that cholesterol synthesis is inhibited. 2. Increase the low-density lipoprotein receptors on the surface of liver cells, increase the clearance of low-density lipoprotein cholesterol, and also increase the clearance of very low-density lipoprotein, the precursor of low-density lipoprotein. 3. Increase the synthesis of high-density lipoprotein cholesterol, which is beneficial to the transport and removal of cholesterol. The drug ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/366A61K9/20A61K47/38A61K47/36A61K47/32A61K47/26A61K47/02A61K47/04A61P3/06
Inventor 曾培安胡良红吴健民张静刘娟
Owner KAMP PHARMA
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